CN114681474B - Composition with detumescence and antipruritic effects - Google Patents

Composition with detumescence and antipruritic effects Download PDF

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Publication number
CN114681474B
CN114681474B CN202210504225.5A CN202210504225A CN114681474B CN 114681474 B CN114681474 B CN 114681474B CN 202210504225 A CN202210504225 A CN 202210504225A CN 114681474 B CN114681474 B CN 114681474B
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test
composition
saponin
pulsatilla
group
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CN114681474A (en
Inventor
杨世林
蓝志杰
胡幼林
赵俊卿
宋洋洋
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Guangxi Linyang Pharmaceutical Co ltd
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Guangxi Linyang Pharmaceutical Co ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7024—Esters of saccharides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/04—Antipruritics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]

Abstract

The invention discloses a composition with the effects of detumescence and antipruritic, which is a preparation prepared by taking pulsatilla root saponin B4 and pulsatilla root saponin B5 as active ingredients and adding pharmaceutically acceptable auxiliary materials; the mass ratio of the pulsatilla saponin B4 to the pulsatilla saponin B5 is 2-8: 2 to 8. The composition taking the pulsatilla root saponin B4 and the pulsatilla root saponin B5 as active ingredients can effectively resist inflammation and detumescence, has obvious antipruritic effect, has no adverse reactions such as allergy and the like, can protect skin from being damaged by chemical components while being used for treatment, and has clinical popularization and application values.

Description

Composition with detumescence and antipruritic effects
Technical Field
The invention particularly relates to a composition with the effects of detumescence and antipruritic.
Background
In spring and summer, various insects are active along with rising of air temperature, pimples, wind clusters, erythema, blisters and dunes caused by mosquito bites cause stinging, burning pain and itching at different degrees, and severe scratching and crushing are caused, so that secondary infection is caused, and daily life and rest illumination of people are seriously influenced.
The biting by mosquitoes is difficult to avoid and the rapid elimination of the symptoms of redness, thermal pain and itching caused thereby remains a difficult problem. Most of the existing medicines for relieving itching and detumescence caused by mosquito bites are antiallergic and hormonal western medicines, local topical glucocorticoid preparations for patients with mild symptoms, topical calamine lotion and other antipruritic agents, antihistamine medicines can be taken for patients with extensive skin damage and serious symptoms, and short-term oral glucocorticoid medicines for patients with serious anaphylaxis and antibacterial medicines for patients with secondary infection.
The external preparation commonly used in the market at present is most common in glucocorticoid cream, has remarkable anti-inflammatory effect, but has poor antipruritic effect, while wiping medicaments such as floral water, electrodeless paste, calamine lotion and the like have better antipruritic effect, but have difficult repercussive and analgesic effects, and especially have great production and development and skin injury to children aiming at infants which are easy to be bitten by mosquitoes, and hormone and chemical medicaments containing alcohol component classification.
In recent years, natural plants have been receiving increasing attention, and active ingredients of natural plants are main active substances for treating and preventing various diseases, so intensive research and development of active ingredients of plants are a hot spot of current research. Liu Xianjun and the like, and the extraction and antibacterial activity test [ J ] of the pulsatilla chinensis, in 2012 (volume 48) of the journal of Chinese veterinarian, disclose that the pulsatilla chinensis saponin extract has antibacterial and anti-inflammatory effects, and since the skin can produce inflammatory reaction after mosquito bites, the pulsatilla chinensis saponin extract can be externally applied to the skin to prevent wound infection, but cannot necessarily produce the effects of relieving itching, detumescence and repairing the skin, therefore, the development of a medicament with detumescence and antipruritic effects by taking natural plant components as medicinal effect components is necessary.
Disclosure of Invention
In order to solve the problems, the invention provides a composition with the effects of detumescence and antipruritic, which comprises the following components of pulsatilla root saponin B4 and pulsatilla root saponin B5, wherein the mass ratio of pulsatilla root saponin B4 to pulsatilla root saponin B5 is 2-8: 2 to 8.
Further, the mass ratio of the pulsatilla saponin B4 to the pulsatilla saponin B5 is 8:2.
further, the preparation is prepared by taking pulsatilla root saponin B4 and pulsatilla root saponin B5 as active ingredients and adding pharmaceutically acceptable auxiliary materials.
Further, the preparation is an external preparation.
Further, the external preparation is a solution, a paste, a gel, an emulsion, a suspension, a powder or a powder.
Further, the auxiliary materials of the ointment or gel comprise animal fiber, plant fiber, wax, paraffin, starch, tragacanth, cellulose derivative, polyethylene glycol, silica gel, bentonite, silica, talcum powder or zinc oxide and the like as carrier components.
Further, the powder auxiliary materials comprise lactose, talcum powder, silicon dioxide, aluminum protein, calcium silicate or chinlon powder; when the powder is used as a spray, a propellant such as fluorocarbon, propane, carbon, dimethylbutane, or the like may be additionally contained.
Still further, the adjuvants of the solution or emulsion include water, ethanol, isopropanol, ethyl carbonate, ethyl acetate, benzyl alcohol, benzyl benzoate, propylene glycol, 1, 3-butylene glycol oil, glycerin aliphatic ester, polyethylene glycol or fatty acid esters of sorbitan.
Further, the auxiliary materials of the suspension comprise water, ethanol or propylene glycol, ethoxylated isostearyl alcohol, polyoxyethylene sorbitol ester, polyoxyethylene sorbitan ester, microcrystalline cellulose, aluminum metahydroxide, bentonite and agar.
Further, each unit preparation of the external preparation contains 25-50 mg of pulsatilla saponin B4 and pulsatilla saponin B5.
Further, each unit preparation of the external preparation contains pulsatilla saponin B4 and pulsatilla saponin B5 30mg.
The invention also provides a preparation method of the composition, which comprises the following steps:
(1) Weighing the raw materials according to the proportion;
(2) Mixing the pulsatilla root saponin B4 and pulsatilla root saponin B5 with pharmaceutically acceptable auxiliary materials.
The invention finally provides application of the composition in preparing a medicament for detumescence and antipruritic.
The structural formula of the pulsatilla saponin B4 used in the invention is as follows:
the structural formula of the pulsatilla saponin B5 used in the invention is as follows:
the composition taking the pulsatilla root saponin B4 and the pulsatilla root saponin B5 as active ingredients can effectively resist inflammation and reduce swelling, has obvious itching relieving effect, has no adverse reactions such as allergy and the like, can protect skin from being damaged by chemical components while being used for treatment, and has clinical popularization and application values.
It should be apparent that, in light of the foregoing, various modifications, substitutions and alterations can be made herein without departing from the spirit and scope of the invention as defined by the appended claims.
The above-described aspects of the present invention will be described in further detail below with reference to specific embodiments in the form of examples. It should not be understood that the scope of the above subject matter of the present invention is limited to the following examples only. All techniques implemented based on the above description of the invention are within the scope of the invention.
Detailed Description
EXAMPLE 1 inventive composition
The formula comprises the following components: pulsatilla saponin B4:8 parts of pulsatilla root saponin B5:2 parts of
The preparation method comprises the following steps: weighing pulsatilla saponin B4 and pulsatilla saponin B5 according to a proportion, adding pharmaceutically acceptable auxiliary materials, and mixing to obtain the Chinese medicinal composition.
EXAMPLE 2 compositions of the invention
The formula comprises the following components: pulsatilla saponin B4:6 parts of pulsatilla root saponin B5:4 parts of
The preparation method comprises the following steps: weighing pulsatilla saponin B4 and pulsatilla saponin B5 according to a proportion, adding pharmaceutically acceptable auxiliary materials, and mixing to obtain the Chinese medicinal composition.
EXAMPLE 3 compositions of the invention
The formula comprises the following components: pulsatilla saponin B4:4 parts of pulsatilla root saponin B5:6 parts of
The preparation method comprises the following steps: weighing pulsatilla saponin B4 and pulsatilla saponin B5 according to a proportion, adding pharmaceutically acceptable auxiliary materials, and mixing to obtain the Chinese medicinal composition.
EXAMPLE 4 compositions of the invention
The formula comprises the following components: pulsatilla saponin B4:2 parts of pulsatilla root saponin B5:8 parts of
The preparation method comprises the following steps: weighing pulsatilla saponin B4 and pulsatilla saponin B5 according to a proportion, adding pharmaceutically acceptable auxiliary materials, and mixing to obtain the Chinese medicinal composition.
The advantageous effects of the present invention are described below by way of test examples.
Test example 1 study of anti-swelling and antipruritic drugs
1. Test article
Composition (1): pulsatilla saponin B4:10 parts of pulsatilla root saponin B5:0 part of
Composition (2): pulsatilla saponin B4:8 parts of pulsatilla root saponin B5:2 parts of
Composition (3): pulsatilla saponin B4:6 parts of pulsatilla root saponin B5:4 parts of
Composition (4): pulsatilla saponin B4:4 parts of pulsatilla root saponin B5:6 parts of
Composition (5): pulsatilla saponin B4:2 parts of pulsatilla root saponin B5:8 parts of
Composition (6): pulsatilla saponin B4:0 parts of pulsatilla root saponin B5:10 parts of
2. Test method
1. Safety performance verification-human body patch test to detect whether adverse reaction to human skin exists
1.1 selecting as a subject volunteer who simultaneously meets the following conditions:
1) The age is between 15 and 60 years old, and the male and female can both use the same;
2) No serious disease, no immunodeficiency or autoimmune disease, no skin treatment or cosmetology of the tested part;
3) No active allergic disease;
4) For those who did not use any anti-inflammatory drugs in the tested parts in the last two months;
5) Those who have not used antihistamines for the last week or immunosuppressants for the last month;
6) Patch testers were not performed for nearly one month.
Exclusion criteria:
1) Pregnant or lactating women;
2) Any external medicine is applied to the tested part in the last two months;
3) Clinically unhealed patients with inflammatory skin diseases;
4) A determination that the test results are affected by scars, pigments, atrophy, moles, or other blemishes in the area of the skin to be measured;
1.2 test methods
The 72 volunteers signed the volunteer's informed consent, and were divided into 6 groups of 12 persons each, and the tested area was the cheekbone part of the face. Prior to each test, the subjects cleaned their faces uniformly and blotted with a chipless blotter dry paper towel. And sitting still for at least 20min in a test environment meeting the standard, and can not drink water and beverage. The subject remained relaxed, with the face exposed, avoiding touching. The left and right parts are sample smearing side and control side, which ensure that the sample smearing side and the control side reach balance in statistics, the measuring areas are respectively determined at the left and right frontal bone parts, the area of each measuring area is 1cm multiplied by 1cm, the composition (1), the composition (2), the composition (3), the composition (4), the composition (5) and the composition (6) are respectively dissolved into liquid with the concentration of 30mg/ml by using sterile water to be used as test liquid, a piece of filter paper is put into a spot tester small test, quantitative test liquid is dripped, and a spot test tape added with the test liquid is attached to the cheekbone position of a volunteer. After 24h and 48h respectively, the skin state was observed
1.3 test results
The test results show that the patch is uncovered for 24 hours and 48 hours, and red spots, oedema and itching and tingling pain are not generated when the left and right cheekbones of 72 volunteers are compared.
2. Pharmacological test verification
2.1 test of skin itch in guinea pigs caused by histamine phosphate
90 normal guinea pigs, which are 9 groups of male and female half with weight of 250+/-20 g, after conventional feeding for 7d, 10 normal saline control groups, respectively, test 1 group (composition (1) is a test drug), test 2 group (composition (2) is a test drug), test 3 group (composition (3) is a test drug, test 4 group (composition (4) is a test drug), test 5 group (composition (5) is a test drug), test 6 group (composition (6) is a test drug), and the compositions in the above test groups are respectively dissolved with sterile water to a concentration of 30mg/ml as a test liquid, and dexamethasone groups and tranilast component cages are stored and numbered.
1 day before the test, the backs of the right back feet of the guinea pigs of each group are shaved by an electric hair clipper, 8% sodium sulfide is used for dehairing, and the area is about 1cm 2 On the day of the test, the skin at the dehairing place is gently scratched by using 800-mesh fine sand paper to make the dehairing place red until no blood seeps. The corresponding liquid medicine is respectively smeared at the positions of the scratches, 0.05mL of 0.5% histamine phosphate solution is dripped at the positions of the foot back wound surface after 20min of administration, and the pruritus latency period, the pruritus frequency and the pruritus duration time within 15min are recorded. The back of the right foot is licked and gnawed by guinea pigs as itch indication, and the duration of itch is recorded for more than 3 seconds and less than 3 seconds as 1 time. The specific test results are shown in Table 1.
TABLE 1 results of test for skin itch caused by histamine phosphate
According to the test results, each index of the test group 2 is obviously superior to the other groups, and the pruritus latency is not obvious different from that of the test group 3 and the test group 4. But the number of itching and the duration of itching were significantly lower than those of trial 3 and trial 4, with a significant difference in the number of itching and the duration of itching compared to the usual antipruritic dexamethasone and the antiallergic agent tranilast.
2.2 test for mice ear swelling caused by xylene
90 normal laboratory mice, 20+ -2 g in weight, each half of the male and female animals, were randomly divided into 9 groups after 7d of normal feeding, 10 groups each were physiological saline control group, test 1 group (composition (1) was a test drug), test 2 group (composition (2) was a test drug), test 3 group (composition (3) was a test drug, test 4 group (composition (4) was a test drug), test 5 group (composition (5) was a test drug), test 6 group (composition (6) was a test drug), and the compositions in the above test groups were dissolved with sterile water as a 30mg/ml liquid as a test liquid, dexamethasone groups, and tranilast component cages were stored and numbered.
The front and back sides of the right ear of each test group of mice are uniformly coated with 0.05mL of dimethylbenzene, after 30min, the front and back sides of the right ear of each group of mice are uniformly coated with 0.05mL of corresponding liquid medicine, the left ear is used as a control, after 120min of administration, the mice are killed by cervical dislocation, ears are cut off along the auricle baseline, ears are cut off at the same position of the left and right ears by a puncher with the diameter of 7mm, and immediately and precisely weighing is performed. The specific results are shown in Table 2.
TABLE 2 results of xylene-induced ear swelling test
Group of Number of animals Ear swelling degree (mg)
Physiological saline control group 10 9.31±1.15
Test 1 group 10 8.86±1.07
Test 2 groups 10 2.04±0.41
Test 3 groups 10 6.66±0.77
Test 4 groups 10 8.20±1.56
Test 5 groups 10 8.72±1.33
Test 6 groups 10 9.22±1.94
Dexamethasone group 10 6.63±1.97
Tranilast group 10 8.92±1.33
Note that: ear swelling degree = weight of right ear-weight of left ear
From the results in the table, the example 2 group had the most remarkable inhibitory effect on ear swelling of mice, the example 3 group had the same effect on ear swelling, and the dexamethasone group in the control group had an effect on ear swelling, but the difference from the test 2 group was remarkable. While the tranilast group had no obvious effect on inhibiting swelling.
2.3 in vivo inhibition of the mechanism of itch the itching caused by mosquito bites is mainly due to the secretion of histamine in tissues, so 4-aminopyridine was used to simulate mosquito bites and to detect histamine levels in skin and blood at the corresponding locations.
90 normal laboratory mice, 20+/-2 g in weight, 10 normal laboratory mice in 9 groups after 7d of normal rearing, respectively, physiological saline control groups, 1 group (composition (1) is a test drug), 2 group (composition (2) is a test drug), 3 group (composition (3) is a test drug, 4 group (composition (4) is a test drug), 5 group (composition (5) is a test drug), 6 group (composition (6) is a test drug), and the compositions in the test groups are respectively dissolved with sterile water to a concentration of 30mg/ml as a test liquid, and dexamethasone group and tranilast group are stored in cages and numbered.
The back was shaved by Mao Yao to cmX cm, 1mg/kg of 4-aminopyridine was subcutaneously injected at the shaved area, and at the same time, the medicine was applied to the shaved area, and after 10 minutes, the materials were taken, blood and skin filtrates were prepared, and the histamine content therein was examined. The specific results are shown in Table 3.
TABLE 3 results of blood Histamine content
Group of Skin histamine content (μg/g) Blood histamine content (μg/g)
Physiological saline control group 6.37±1.58 2.42±0.30
Test 1 group 5.82±1.77 2.59±0.87
Test 2 groups 1.38±1.22 0.61±0.12
Test 3 groups 5.13±1.54 1.68±0.71
Test 4 groups 5.74±1.62 1.96±0.53
Test 5 groups 5.76±1.81 1.93±0.37
Test 6 groups 6.21±1.68 2.38±0.86
Dexamethasone group 3.87±1.09 1.68±0.22
Tranilast group 2.84±1.74 0.78±0.06
From the test results in the table, the test 2 group and the tranilast group can effectively inhibit the content of histamine in tissues and blood, and the difference is significant compared with the dexamethasone group.
3. Performance verification
According to the early test results, selecting a test 2 group and a test 3 group as test groups, taking physiological saline as a control group, taking a dexamethasone group and a tranilast group as control medicine groups, and performing an affected part smearing test on patients suffering from the light bite of mosquitoes. The test results were recorded for 10 persons per group. The specific results are shown in Table 4.
Table 4 results of performance verification
According to the test results, compared with the other groups, the test 2 groups have obvious improvement effect on the red swelling of the affected part bitten by mosquitoes, reduce the duration of pruritus, and have smaller side effects on human bodies compared with the commonly used hormone medicines and antiallergic medicines.
4. Conclusion(s)
The patch test proves that the mixture of the pulsatilla root saponin B4 and the pulsatilla root saponin B5 is safe to human skin and has no damage or irritation; compared with the hormone dexamethasone, the composition 2 has obvious antipruritic effect; ear swelling tests prove that the composition 2 has better swelling inhibition effect compared with the antiallergic drug tranilast; the histamine secretion inhibition test shows that composition 2 has better histamine secretion inhibition effect than dexamethasone. In the practical use performance verification, the composition 2 has more advantages in cure rate and effective rate compared with a control group, and the test results show that dexamethasone and tranilast have effects on one aspect, the comprehensive effect is inferior to that of the composition 2, meanwhile, clinical use proves that the currently commonly used hormone medicament dexamethasone and antiallergic medicament tranilast have great side effects on human bodies, and the composition 2 is a component extracted from pure traditional Chinese medicines, so that the composition is safe and free of side effects.
The composition taking the pulsatilla root saponin B4 and the pulsatilla root saponin B5 as active ingredients can effectively resist inflammation and reduce swelling, has obvious itching relieving effect, has no adverse reactions such as allergy and the like, can protect skin from being damaged by chemical components while being used for treatment, and has clinical popularization and application values.

Claims (4)

1. A composition with the functions of detumescence and antipruritic, which is characterized in that: the composition is an external preparation prepared by taking anemonin B4 and anemonin B5 as active ingredients and adding pharmaceutically acceptable auxiliary materials;
the mass ratio of the pulsatilla saponin B4 to the pulsatilla saponin B5 is 8:2.
2. the composition of claim 1, wherein: the external preparation is solution, ointment, gel, emulsion, suspension, powder or powder.
3. A process for the preparation of a composition according to claim 1 or 2, characterized in that: it comprises the following steps:
(1) Weighing raw materials according to the proportion of claim 1;
(2) Mixing the pulsatilla root saponin B4 and pulsatilla root saponin B5 with pharmaceutically acceptable auxiliary materials.
4. Use of a composition according to claim 1 or 2 for the preparation of a medicament for detumescence and antipruritic.
CN202210504225.5A 2022-05-10 2022-05-10 Composition with detumescence and antipruritic effects Active CN114681474B (en)

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CN111110728A (en) * 2020-02-14 2020-05-08 广西英路维特药物有限公司 Pulsatilla chinensis extract and application thereof in preparation of medicines for preventing and/or treating cow mastitis
CN112569190A (en) * 2020-12-31 2021-03-30 苏州大学 Oral administration preparation of pulsatilla chinensis saponin B4 and preparation method thereof
CN113318002A (en) * 2021-06-12 2021-08-31 广西馨海药业科技有限公司 Anti-inflammation acne-removing composition and cosmetic
CN113893315A (en) * 2021-11-25 2022-01-07 顾帆 Anti-inflammation, detumescence and itching-relieving ointment for mosquito bites and preparation method thereof
CN114159453A (en) * 2021-12-24 2022-03-11 广西馨海药业科技有限公司 Application of pulsatilla chinensis saponin B4 in preparation of medicine for treating or preventing psoriasis
CN114209739A (en) * 2021-12-16 2022-03-22 江西中医药大学 Application of pulsatilla chinensis extract in preparation of antidepressant drug
CN114306359A (en) * 2022-03-14 2022-04-12 中国中医科学院中药研究所 Analgesic application of pulsatilla chinensis or extract thereof

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Publication number Priority date Publication date Assignee Title
CN111110728A (en) * 2020-02-14 2020-05-08 广西英路维特药物有限公司 Pulsatilla chinensis extract and application thereof in preparation of medicines for preventing and/or treating cow mastitis
CN112569190A (en) * 2020-12-31 2021-03-30 苏州大学 Oral administration preparation of pulsatilla chinensis saponin B4 and preparation method thereof
CN113318002A (en) * 2021-06-12 2021-08-31 广西馨海药业科技有限公司 Anti-inflammation acne-removing composition and cosmetic
CN113893315A (en) * 2021-11-25 2022-01-07 顾帆 Anti-inflammation, detumescence and itching-relieving ointment for mosquito bites and preparation method thereof
CN114209739A (en) * 2021-12-16 2022-03-22 江西中医药大学 Application of pulsatilla chinensis extract in preparation of antidepressant drug
CN114159453A (en) * 2021-12-24 2022-03-11 广西馨海药业科技有限公司 Application of pulsatilla chinensis saponin B4 in preparation of medicine for treating or preventing psoriasis
CN114306359A (en) * 2022-03-14 2022-04-12 中国中医科学院中药研究所 Analgesic application of pulsatilla chinensis or extract thereof

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